Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507228
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
North West London Pebble Pathway Automated OSA Diagnosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
North West London Pebble Pathway Automated OSA Diagnosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEBBLE
Brief Summary:
Patients with obstructive sleep apnoea OSA wait up to two years for a diagnostic test Early diagnosis enables optimal treatment mitigating risks including heart failure lung disease and stroke Current diagnostic approaches are expensive 391 time-consuming 1-hour interpretation uncomfortable cablestubeswires and inequitable multiple hospital visits Overcoming all these limitations we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA This will use the AcuPebble a miniature wearable acoustic sensor and the first regulated technology for automated at-home diagnosis The test is cheap 100 time-saving endorsed by patients and accessible posted directly to patients This project will measure the impact of a potentially transformative innovative and scalable diagnostic pathway using AcuPebble technology
Detailed Description:
The investigators are conducting a prospective implementation and health economic study of a novel straight-to-test STT clinical diagnostic pathway for OSA using a novel regulatory-approved wearable medical device for automated diagnosis of OSA in the home setting AcuPebble SA100 The setting is real-world direct clinical care with participation from three NHS sleep medicine centres servicing the North West London region
Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy CR-PG technology serving as a control group The primary outcome is time-to-diagnosis Secondary outcomes include NHS cost-saving per patient surrogates for health equity eg test completion rates timecost of journeys saved and carbon footprint reduction from averted patient journeys sustainability
Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy CR-PG technology serving as a control group The primary outcome is time-to-diagnosis Secondary outcomes include NHS cost-saving per patient surrogates for health equity eg test completion rates timecost of journeys saved and carbon footprint reduction from averted patient journeys sustainability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None